BRCA1/2 Gene Patents Invalidated: Is it Finally about the Patient?

Earlier this week a district court in a dramatic decision invalidated BRCA 1/2 – two breast cancer gene patents held by Myriad Genetics. The Court based its decision on patent subject matter analysis holding that since the isolated DNA covered by Myriad’s patents is not markedly different from the native DNA as it exists in nature, it qualifies as a product of nature, which is not patentable subject matter.

No doubt, as commentators have noted (here and here), this decision if not overturned or limited on appeal could carry broad ramifications for the future gene patents. But, this decision signifies also a change in strategy in the efforts to restrict gene patents – a focus on the patient.

As I have written, most of the debates on gene patents addressed the way that gene patents affect genetic research – the concern that granting patents on the building blocks of genetic science will hinder the development of more complex innovations. Unsurprisingly, most academic proposals and legislative bills address the innovation problem. The effects on the patient until now took a back seat.

This lawsuit against Myriad signifies a change in that it finally places the patient and the administration of genetic testing at the center of the stage. Although the Court’s holding focuses on patent subject matter the court dedicates a significant part of the opinion to access to BRCA1/2 genetic testing. Myriad charges about $3,000 for testing an exorbitant amount compared to other genetic tests. Furthermore, Myriad does not allow other laboratories to conduct the testing – all samples have to be sent to its headquarters in Salt Lake City. The opinion tells the stories of women who were unable to test to find out whether they carry the BRCA1/2 genes because Myriad would not accept their insurance. It recounts the ordeals of women who could not get definitive answers through Myriad’s testing and were precluded from seeking testing elsewhere. It underscores that women were unable to get a second opinion of the test results because tests are conducted only by Myriad. It also discusses the efforts of doctors and laboratories who were willing and able to offer BRCA1/2 testing but were precluded by Myriad from conducting the testing.

Although the Court’s analysis of patentable subject matter is not directly related to the issue of access, the detailed discussion of patients interests shows that these interests played a role in the Court’s decision. Myriad Genetics is not the only patent owner of genetic testing who hinders access to genetic testing technology. It would be interesting to see if this case will drive a strategic change in patent litigation and legislative proposals that have so far focused mainly on innovation and research in the area of genetics.